Pauline Anderson

May 31, 2017

SAN DIEGO, California ― A novel dopamine and norepinephrine reuptake inhibitor is showing promise in patients with binge eating disorder (BED).

Patients taking dasotraline had significantly fewer episodes of binge eating compared to those taking a placebo, a new phase 2/3 clinical trial showed.

"We are encouraged by these results because there's still an unmet need in terms of bringing additional treatments that may be potentially efficacious and safe for the treatment of binge eating disorder," Robert Goldman, PhD, head of global clinical research and medical affairs, Sunovion, told Medscape Medical News.

The research was presented here at the American Psychiatric Association (APA) Annual Meeting.

Uncomfortably Full

BED is characterized by recurrent episodes of compulsive overeating during which individuals consume larger than normal amounts of food and may have the sense that they lack control. Patients with this condition eat when they're not hungry and often eat to the point of feeling uncomfortably full.

Binge eaters may feel embarrassed by how much they consume, which may contribute to social isolation. BED may lead to weight gain and to health problems related to obesity.

The new study included 317 patients (mean age, 38.2 years). The mean body mass index (BMI) was 34.7. Dr Goldman noted that 75% of study participants were classified as obese (BMI ≥30 or more).

Patients had to have moderate to severe BED, characterized by two or more binge eating days per week for 6 or more months, and three or more binge eating days per week for each of the 2 weeks prior to the trial.

About 84% of the study participants were women. Epidemiologic studies show that the lifetime prevalence of BED is higher among women (3.6%) than among men (2.1%), said Dr Goldman.

At baseline, the mean number of binge eating days per week among study participants was 4.25, and their mean Clinical Global Impression–Severity (CGI-S) score was 4.5.

Participants were randomly allocated to receive either oral dasotraline or placebo taken daily in the morning. The study used "flexible" dosing. The initial dose was 4 mg; the dose could be increased to 6 mg after 2 weeks, and clinicians could opt to increase it to 8 mg at subsequent visits, said Dr Goldman.

Dasotraline has a slow rate of absorption and a long half-life. "You achieve stable plasma concentrations over 24 hours at the once-daily dosing," commented Dr Goldman.

A mixed model for repeated measures analysis showed that at week 12, the number of binge days per week was reduced by 3.74 in patients taking dasotraline and by 2.75 in the placebo group (for a mean difference of -0.99; 95% confidence interval, -0.65 to -1.33; P < .001).

As for secondary endpoints, 46.5% in the treatment group had at least 4 consecutive weeks in which they did not binge eat, compared to 20.6% of the placebo group (P < .001). As well, scores on the CGI-S and on the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating were significantly better in the treatment group compared to the placebo group.

Adverse Events

More participants taking dasotraline had treatment-related adverse events, including insomnia, dry mouth, decreased appetite, and nausea, compared to the placebo group. Weight loss also occurred more frequently in the the treatment group (12.1% vs 0%).

"These adverse events are consistent with other studies in adults and are consistent with the dopamine/norepinephrine pharmacology of the agent, so they're not surprising," said Dr Goldman.

He stressed that in the dasotraline group, only 1.3% of participants discontinued the drug because of insomnia, and 1.9% discontinued it because pf anxiety.

Could this drug be used as a weight loss drug? Dr Goldman noted that, should this agent be approved, the label would clearly stipulate its use for treating BED.

He also pointed to a study evaluating the abuse potential of dasotraline, which is also being developed for the treatment of attention-deficit/hyperactivity disorder. That analysis indicated low potential for its abuse compared with the stimulant methylphenidate among recreational stimulant users.

It is not yet clear whether women responded better than men to the agent. "We are doing additional analyses of various subgroups, and that would include sex," said Dr Goldman. "At this point, I can't speak about specific subgroup effects."

Patients with BED sometimes receive psychotherapeutic interventions, often combined with pharmacologic treatment. Lisdexamfetamine dimesylate (Vyvanse, Shire) is the only medication approved by the US Food and Drug Administration to treat BED.

A second confirmatory pivotal trial is being carried out in patients with moderate to severe BED.

Another Alternative?

Medscape Medical News approached Sanjeev Sockalingam, MD, associate professor, Department of Psychiatry, University of Toronto, and psychosocial director, Toronto Western Hospital Bariatric Surgery Program, for comment.

Dr Sockalingam emphasized that physicians currently have only one approved medication for the treatment of patients with BED.

"This study provides data suggesting that dasotraline may be another promising treatment alternative. It adds to the limited literature on pharmacological treatments that are beneficial for more severe BED," he said.

Additional therapeutic options might complement evidence-based psychological treatments for BED, he added.

New treatment options are needed, said Dr Sockalingam, given that BED is associated with an increased risk for other psychiatric disorders and obesity.

He stressed the need for additional research to establish the optimal treatment duration and the long-term safety of this novel agent.

Dr Goldman is an employee of Sunovion. Dr Sockalingam has received an investigator-initiated research grant from Shire Pharmaceuticals.

American Psychiatric Association (APA) 2017 Annual Meeting. Abstract P7-084, presented May 23, 2017.

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